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REACH Authorisation
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Identification of Substances of Very High Concern

The Process

► What are the characteristics of relevant SVHCs? Preparing the Annex XV report and Public Consultation

1. In Practice

Risk Management Options Analysis

The Roadmap for Substances of Very High Concern mentioned earlier in this Guide is based on the Risk Management Options (RMO) approach. Consistent with the principles of better regulation, the Risk Management Options Analysis (RMOA) identifies the best regulatory option to manage the risk, either in REACH (Authorisation, Restriction or Substance Evaluation) or outside of REACH (with another legislation).

Do plan and get organised to contribute as much as possible to the RMO analysis. The trade associations or consortia can play a key role to support you!

The main objective is to have all relevant currently known Substances of Very High Concern (SVHCs) included in the Candidate List by 2020. The Commission considers that no numerical goal should be identified in the Roadmap for the number of substances that will be included in the Candidate List, as it cannot be pre-judged without a thorough RMO analysis.

The Roadmap clearly stresses that RMO analysis is a voluntary but critical step in the definition of the relevance of the SVHC. The level of detail needed to reach a conclusion in the RMOA will highly depend on the complexity of the case and the available information.

However, considering the political pressure to increase the number of substances on the Candidate List and potentially on Annex XIV, the Commission wants to focus and simplify the RMO analyses. It would like to consider grouping substance for the RMO analysis based on properties and uses.

The RMOA is not meant to be public and no consultation of stakeholders is foreseen. However the authority drafting the RMO can consider if publication and consultation is appropriate.

The RMOA is voluntary and its level of detail is left to the proposing authority (Member State or ECHA). Hence the quality of the RMOA may also depend greatly on the willingness and capacity of the industry concerned to provide input to the process.

Do consider preparing your own shadow RMO analysis so as to have a structured intellectual framework to discuss with the drafters or reviewers of the official RMOA. Trade association or consortia can coordinate such a type of exercise.

Not all Member States are keen to involve industry at the early stage so as not to antagonise and encourage pressure from other stakeholders such as environmental NGOs or trade unions. France and Germany, are among those countries with established means of consultation with their industry. It is worth noting that in the case of the RMOA on nickel containing chemicals, the level of detail is high due to the complexity of the case and the amount of information already available to the French authorities.

RMOs include any possible changes to legislation or other requirements of industry (e.g. permits) to control identified risks. RMOs may also cover the use of economic instruments and industry’s voluntary commitments. A Restriction is one type of RMO.

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